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Recruiting Phase 2

Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction

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About this study

Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The objectives of SCHOLAR-2 are to evaluate whether is it safe and effective to continue trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2 positive breast cancer despite mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction as compared with a guideline-driven approach of withholding or discontinuing trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1). In SCHOLAR-2, we will compare two thresholds of withholding or discontinuing trastuzumab/pertuzumab/trastuzumab-emtansine: a threshold that is currently advocated for by existing treatment practice guidelines versus a more aggressive threshold that allows trastuzumab/pertuzumab/trastuzumab-emtansine to continue at lower levels of LVEF than currently supported by guideline documents.

Condition
Breast Cancer, Heart Failure
Tested
Trastuzumab, Pertuzumab, Trastuzumab emtansine
Sponsor
Population Health Research Institute

Who can join

Age
Not specified
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 5

  • Study condition: Breast Cancer, Heart Failure
  • Stage I-III HER-2 positive breast cancer
  • Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
  • Evidence of left ventricular dysfunction, as defined by at least one of:
  • a) LVEF \< 54% or b) LVEF ≥54% and either i) fall in LVEF of ≥15% from prior to trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) exposure, or ii) New York Heart Association (NYHA) class II heart failure symptoms within the past 6 months

Exclusion 6

  • Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker
  • Contra-indication to both ACE-I/ARB and beta-blockers
  • NYHA class III or IV heart failure
  • LVEF \<40%
  • Systolic blood pressure \<100mmHg
  • Current or planned pregnancy or breastfeeding

Where

8 sites, 7 recruiting

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Recruiting

Irmandade Da Santa Casa De Misericórdia De Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Recruiting

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Recruiting

Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

São Paulo, São Paulo, Brazil

Recruiting

Juravnski Cancer Centre

Hamitlon, Ontario, Canada

Recruiting

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Recruiting

and 2 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.